TREATMENT OF OROPHARYNGEAL CANDIDIASIS IN IMMUNOCOMPETENT INFANTS - ARANDOMIZED MULTICENTER STUDY OF MICONAZOLE GEL VS NYSTATIN SUSPENSION

Background. Miconazole gel has previously been shown to be an effectiv e treatment for oropharyngeal candidiasis (thrush) in immunocompetent infants. This study compares miconazole gel with the standard therapeu tic agent, nystatin suspension, with regard to efficacy, optimal durat ion of therapy and safety. Design. Prospective multicenter, randomized , office-based open trial. Patients. Twenty-six pediatricians enrolled 227 immunocompetent infants with signs of oropharyngeal thrush. Subje cts were randomly assigned to receive 25 mg of miconazole as oral gel four times daily or 100000 IU of nystatin as suspension four times dai ly after meals. All subjects were evaluated for safety. Fifteen patien ts whose thrush was not confirmed by culture were excluded from furthe r analysis. The remaining 212 subjects were entered into an intention- to-treat analysis, Another 29 patients violated the study protocol; th e remaining 183 subjects were evaluated for efficacy (per protocol ana lysis). Results. Clinical cure by Day 5 of treatment was demonstrated in 84.7% of the 98 subjects in the miconazole group and 21.2% of the 8 5 subjects in the nystatin group (P < 0.0001). By Day 8, the cumulativ e clinical cure rates were 96.9% (miconazole) and 37.6% (nystatin), re spectively (P < 0.0001). By Day 12, 99.0% of subjects in the miconazol e group and 54.1% of subjects in the nystatin group were clinically cu red (P < 0.0001). Premature cessation of treatment at parents' request because of lack of clinical efficacy occurred in none of the infants treated with miconazole and in 6 infants treated with nystatin (P 0.02 9). The oral yeast eradication rate on Day 5 was 54.1% with miconazole and 8.2% with nystatin (P < 0.0001). Clinical relapses of oropharynge al thrush and side effects of the study drugs were observed with simil ar frequency in both study arms. Conclusions. Miconazole gel was signi ficantly superior to nystatin suspension with regard to efficacy, rapi dity of achieving cure and oropharyngeal yeast eradication. Relapses a nd side effects did not occur more frequently with miconazole than wit h nystatin. The results of this study indicate that miconazole gel is superior to nystatin suspension as the treatment for oropharyngeal can didiasis in immunocompetent infants.